Regulatory Affairs Specialist

Position Overview

The Regulatory Affairs Specialist for Medical Devices is responsible for managing regulatory activities required to ensure timely approval, compliance, and continued market access of medical device products in the Philippines. This includes overseeing product registrations with the Philippine FDA – Center for Device Regulation, Radiation Health, and Research (CDRRHR), maintaining regulatory compliance throughout the product lifecycle, and supporting cross‑functional teams on regulatory and technical matters.

Key Responsibilities

1. Regulatory Strategy & Compliance

• To support timely product approvals and market access for medical devices.
• Ensure full compliance with Philippine FDA (CDRRHR) regulations and relevant local administrative orders.
• Monitor regulatory changes and interpret their impact on current and future products; communicate updates to internal stakeholders.

2. Product ...